Consensus recommendations on estrogen receptor testing in breast cancer by immunohistochemistry.
Estrogen receptor (ER) status in breast cancer is currently the most important predictive biomarker that determines breast cancer prognosis after treatment with endocrine therapy. Although immunohistochemistry has been widely viewed as the gold standard methodology for ER testing in breast cancer, lack of standardized procedures, and lack of regulatory adherence to testing guidelines has resulted in high rates of "false-negative" results worldwide. Standardized testing is only possible after all aspects of ER testing--preanalytical, analytical, and postanalytical, have been closely controlled. A meeting of the "ad-hoc committee" of expert pathologists, technologists, and scientists, representing academic centers, reference laboratories, and various agencies, issued standardization testing recommendations, aimed at optimization of clinical ER testing environment, as a step toward improved standardized testing.
Yaziji
Hadi
H
Vitro Molecular Laboratories, Miami, FL daggerKeck School of Medicine, University of Southern California, Los Angeles, USA. vitromolecular@mac.com
Taylor
Clive R
CR
Goldstein
Neal S
NS
Dabbs
David J
DJ
Hammond
Elizabeth H
EH
Hewlett
Bryan
B
Floyd
Alton D
AD
Barry
Todd S
TS
Martin
Alvn W
AW
Badve
Sunil
S
Baehner
Frederick
F
Cartun
Richard W
RW
Eisen
Richard N
RN
Swanson
Paul E
PE
Hewitt
Stephen M
SM
Vyberg
Mogen
M
Hicks
David G
DG
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D014408:Biomarkers, Tumor / Q000378:metabolism*; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000378:metabolism / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D003951:Diagnostic Errors / Q000517:prevention & control; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards; D005260:Female; D006801:Humans; D007150:Immunohistochemistry / Q000379:methods* / Q000592:standards*; D011960:Receptors, Estrogen / Q000378:metabolism*; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000592:standards; D013629:Tamoxifen / Q000008:administration & dosage; D016707:Tissue Fixation / Q000592:standards
D014408:Biomarkers, Tumor; D011960:Receptors, Estrogen; D013629:Tamoxifen